Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease

Effect of adacolumn and adalimumab combination therapy for the active stage Crohn's disease - Effect of adacolumn and adalimumab combination therapy for Crohn's disease

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000007047

Enrollment

Registered

2012-01-10

Start date

2011-11-01

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Crohn&#39

Interventions

Adacolumn and adalimumab combination therapy for 10 weeks. Adalimumab single therapy for remain 94 weeks. Adacolumn single therapy for 104 weeks.

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: The patient that it was judged that keeping blood access was possible. The patient that agreed this study.

Exclusion criteria

Exclusion criteria: Below 2,000 / mm3 granulocyte count Severe infection Severe heart disease Severe Renal disease Systolic blood pressure less than 80mmHg patient with suspected or currently pregnant Increased intensity of extreme dehydration or coagulation system Severe anemia Malignant tumor Short-bowel syndrome Artificial anus External fistula Ileus or svere stenosis of the intestine Extraintestinal complications Recent use of steroid, 5-Aminosalicylic acid, immunomodulator, biologics, elemental diet Recent operation

Design outcomes

Primary

Measure	Time frame
Remission induction rate 11 weeks after the start of therapy. Remission rate 104 weeks after the start of therapy.	—

Secondary

Measure	Time frame
Remission period CT or CT enteroclysis/enterography Change of the CRP Safety	—

Countries

Japan

Contacts

Public ContactShinichi Hashimoto

Yamaguchi University Graduate School of Medicine Department of Gastroenterology and Hepatology

has-333@yamaguchi-u.ac.jp0836-22-2241

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026

Effect of adacolumn and adalimumab combination therapy for the active stage Crohn&#39;s disease